Non Small Cell Lung Cancer Clinical Trial
Official title:
Evaluation of Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash
NCT number | NCT00803842 |
Other study ID # | MEL-120407 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | December 5, 2008 |
Last updated | February 24, 2015 |
Start date | October 2008 |
Verified date | February 2015 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
A side effect occurring in a majority of patients taking erlotinib (Tarceva®) consists of a skin rash. Sometimes, symptoms associated with the rash necessitate erlotinib dose reduction or discontinuation. Some physicians have successfully treated the erlotinib-induced rash with doxycycline. At the same time, it has been observed that in patients who develop the erlotinib rash, the cancers respond better to erlotinib treatment. This research study is designed to determine how well doxycycline treats the erlotinib rash and whether doxycycline affects the blood levels of erlotinib.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Males and females 18 years of age or older. - Subjects must have started Tarceva® therapy within three (3) days of trial enrollment. - Patients must have signed informed consent prior to registration on study. - Currently receiving erlotinib therapy at 150 mg per day for locally advanced or metastatic NSCLC. - Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must utilize barrier methods in combination with spermicidal agents for contraception when engaging in sexual intercourse. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration. Exclusion Criteria: - Allergy to tetracyclines. - Use of concurrent agents for papulopustular rash. - Currently receiving anticancer agents other than erlotinib. - Inability to interrupt other antibiotic therapy. - Current use of topical steroids - Current use of systemic immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine, mycophenolate mofetil) - Photosensitivity or lupus erythematosus. - Active gastroesophageal reflux disease. - Women who have a positive pregnancy test or are lactating by history. - ECOG performance status =3. - Self report of current smoking or history of smoking within 60 days of screening, or positive urine cotinine test. - Current use of agents that are known to be strong inducers or inhibitors of CYTP3A4: - inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfi navir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, grapefruit or grapefruit juice - inducers: rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, and St. John's Wort - Impaired hepatic function (= 30 days before randomization): - Alkaline phosphatase > 3x ULN - Aspartate aminotransferase (AST) > x ULN - Alanine aminotransferase (ALT) > 3 x ULN - Total Bilirubin > 1.5 x ULN |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of this study is to determine whether administration of doxycycline affects erlotinib PK | 14 days | No | |
Secondary | Secondarily, this study aims to investigate the relationship between erlotinib AUC and rash severity and to evaluate the efficacy of doxycycline in rash management. | 14 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Recruiting |
NCT05707286 -
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
|
||
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Completed |
NCT01945021 -
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
|
Phase 2 | |
Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
Terminated |
NCT04022876 -
A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)
|
Phase 1 | |
Recruiting |
NCT05898763 -
TEIPP Immunotherapy in Patients With NSCLC
|
Phase 1/Phase 2 | |
Recruiting |
NCT05532696 -
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
|
Phase 1/Phase 2 | |
Completed |
NCT04311034 -
A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
Terminated |
NCT03257722 -
Pembrolizumab + Idelalisib for Lung Cancer Study
|
Phase 1/Phase 2 | |
Completed |
NCT00349089 -
Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy
|
Phase 2 | |
Completed |
NCT05116891 -
A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04571632 -
Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors
|
Phase 2 | |
Terminated |
NCT03599518 -
DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06020989 -
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
|
Phase 2 | |
Withdrawn |
NCT03982134 -
PDR001 + Panobinostat for Melanoma and NSCLC
|
Phase 1 | |
Withdrawn |
NCT03574649 -
QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer
|
Phase 2 | |
Withdrawn |
NCT02844140 -
DE-CT in Lung Cancer Proton Therapy
|
N/A | |
Completed |
NCT03780010 -
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
|
Phase 1 |